# K130617: Raystation

- Pathway: 510(k) (Traditional)
- Applicant: Raysearch Laboratories AB
- Decided: May 10, 2013 after 64 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862643 (1987). 48 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120387: Raystation, Raysearch Laboratories AB (2012) Summary page 1.
- K020971: DCM 2.0, Mds Nordion AB (2002) Summary page 1.
- K000922: Proton Vision, Varian Assoc., Inc. (2000) Summary page 1.

## Most influential descendants
- K140187: Ray Station (2014), 19 descendants of its own
- K141860: Raystation (2014), 17 descendants of its own
- K160093: RayStation (2016), 16 descendants of its own
- K170355: RayStation 6 (2017), 15 descendants of its own
- K171536: RayStation (2017), 13 descendants of its own

## Recalls of this device
- May 8, 2015 · Class II · Z-1679-2015: RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
- Apr 25, 2014 · Class II · Z-1806-2014: This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects
- Feb 14, 2014 · Class II · Z-1481-2014: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
- Feb 6, 2014 · Class II · Z-1308-2014: RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
- Feb 6, 2014 · Class II · Z-1307-2014: Potential for dose errors due to software program errors.
- Oct 23, 2013 · Class II · Z-0281-2014: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle dif

## Indications for use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K130617
Methodology: https://510kreport.com/methodology